HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA ...
FDA Recall #D-1030-2014 — Class II — December 11, 2013
Product Description
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
Reason for Recall
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Recalling Firm
KVK-Tech, Inc. — Newtown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
14664 bottles
Distribution
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Code Information
lot #11434, exp. Nov-14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated